OBJECTIVES: When treatments are assessed by French National Authority for Health (HAS), a cost-effectiveness analysis is required for products likely to have an economic impact. The HAS gives the manufacturer the opportunity to refine the dossier according to the questions raised during the technical exchange (TE) to avoid reservations. The Commission for Economic and Public Health Evaluation (CEESP) can then assess the efficiency. This research aimed to analyze the impact of questions raised during TE on the reservations in the final opinions.

METHODS: We analyzed the 2022 published opinions. Reservations and TE were assessed and compared to determine the relationship between the reservations and the issues raised during the TE. The comparisons were used to determine if reservations were previously discussed or emerged suddenly, and which aspects could be addressed without leading to reservations.

RESULTS: In total, 28 opinions were analyzed, of which the majority (20) concerned oncology, 3 did not have a TE, and 1 had no opinion due to an unfurnished dossier. From all opinions, there were approximately 800 questions and 237 reservations, among 18 were major. Most reservations (135) and questions (298) involved modelling clarifications including assumptions and survival extrapolations. Questions regarding parametric choices for the model and results were globally addressed by modifying the methodology when raised during TE. Some reservations about transposability and model structure were not preceded by questions during exchanges. Questions about utility were complex to address and lead to most major reservations.

CONCLUSIONS: Analysis of the CEESP opinions revealed that furnishing the effort during TE is important as most of the questions don't conduct to reservations, especially for parametric choices. Most importantly, justifying assumptions, validating models, and considering transposability during the dossier development phase effectively before submission can potentially prevent reservations without questions at the TE. Avoiding reservations will optimize price negociation.